Systems and methods for performing biological assays

Abstract

Systems and methods for performing biological assays are provided herein. The systems and methods determine one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample.

1 .- 78 . (canceled) 
     
     
         79 . A system for performing a biological assay, the system comprising:
 a. a sample preparation device comprising:
 i. a sample receiving module comprising a fluid container comprising a preparation solution; 
 ii. a pressurizing chamber comprising a plunger, wherein the pressurizing chamber is operatively coupled to the sample receiving module; 
   b. an optical property modifying device operatively coupleable to the sample preparation device and comprising:
 i. a sample receiving cartridge operatively coupled to the sample preparation device, comprising one or more reaction chambers each comprising an optical property modifying reagent; and 
 ii. a substrate comprising a heating element; wherein when the optical property modifying device is operatively coupled to the sample preparation device and the plunger is actuated the plunger creates positive pressure in the pressurizing chamber or sample receiving module to transmit at least a portion of the preparation solution from the sample receiving module into the one or more reaction chambers of the sample receiving cartridge, thereby depressurizing the sample receiving module. 
   
     
     
         80 . A method of determining one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample, the method comprising:
 a. collecting a biological sample;   b. providing the system of claim  79 ;   c. inserting the biological sample comprising a nucleic acid into the preparation solution of the sample receiving module of the sample preparation device to produce a prepared nucleic acid amplification sample;   d. operatively coupling the sample preparation device with the optical property modifying device;   e. depressurizing the pressurizing chamber or sample receiving module by transmitting at least a portion of the prepared nucleic acid amplification sample out of the sample receiving module and into one or more reaction chambers of the optical property modifying device, wherein the chambers comprise an optical property modifying reagent and an amplification composition, and thereby generating a nucleic acid reaction mixture;   f. heating the reaction mixture with the heating element of the optical property modifying device, wherein the heating accelerates a nucleic acid amplification reaction comprising the nucleic acid and the amplification composition, the reaction generating an amplified nucleic acid and a plurality of protons;   g. reacting the protons with the optical property modifying reagent, wherein the reacting sufficiently modifies an optical property of the optical property modifying reagent to allow detection of the modified optical property; and   h. determining one or more characteristics of the sample based on the modified optical property.   
     
     
         81 . The system of  claim 79 , further comprising:
 a cap removably couplable to the sample receiving module, wherein coupling the cap to the sample receiving module seals a first opening of the sample receiving module.   
     
     
         82 . The system of  claim 81 , wherein the pressurizing chamber is formed from the fluid container and the cap. 
     
     
         83 . The system of  claim 82 , wherein the cap comprises the plunger. 
     
     
         84 . The system of  claim 81 , wherein the cap further comprises a first chamber, a piercing member, and a breakable seal. 
     
     
         85 . The system of  claim 84  wherein advancing the plunger pierces the breakable seal with the piercing member, thereby placing the first chamber and the fluid container in fluidic communication. 
     
     
         86 . The system of  claim 81 , wherein the cap comprises a receptacle configured to receive an end of the sample receiving module therein when the cap is coupled to the sample receiving module. 
     
     
         87 . The system of  claim 81 , wherein the sample receiving module comprises a first attachment element and the cap comprises a second attachment element operatively coupleable with the first attachment element. 
     
     
         88 . The system of  claim 79 , wherein the sample preparation device further comprises a breakable seal. 
     
     
         89 . The system of  claim 79 , wherein the preparation solution is a nucleic acid amplification preparation solution. 
     
     
         90 . The system of  claim 79 , wherein the substrate comprises a power source operatively coupled to the heating element or a printed circuit board. 
     
     
         91 . The system of  claim 79 , wherein the sample preparation device and the optical property modifying device are each hand-held devices. 
     
     
         92 . The system of  claim 79 , wherein the fluid container has a volume of 50 cm 3  or less. 
     
     
         93 . The system of  claim 79 , further comprising a sample collector. 
     
     
         94 . The system of  claim 79 , wherein the sample receiving module is shaped as a cylinder having a diameter of 5 cm or less and having a height of 20 cm or less. 
     
     
         95 . The system of  claim 79 , wherein the fluid container has a volume ranging from 1 mL to 10 mL. 
     
     
         96 . The system of  claim 79 , wherein the optical property modifying device further comprises an adhesive layer operatively connection the sample receiving cartridge and the substrate and thereby forming a wall of each of the one or more reaction chambers. 
     
     
         97 . The system of  claim 79 , wherein the sample receiving module is adapted to receive one or more portions of a sample collector. 
     
     
         98 . The system of  claim 79 , wherein the sample receiving module comprises an outer body forming a first chamber, and wherein the fluid container comprises a breakable seal and an inner body forming a second chamber, wherein the inner body is movable within the outer body.